Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Mean End-of-Day Comfort
Study Overview
Brief Summary
The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.
Detailed Description
This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is at least 17 years of age and has full legal capacity to volunteer.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Has had an ocular examination in the last two years.
- •Is an adapted soft contact lens wearer.
- •Experiences a decrease in ocular comfort through a lens-wearing day.
- •Has a current pair of spectacles.
- •Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
- •Has astigmatism less than or equal to -1.00 DC.
- •Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Has any ocular disease.
- •Has a systemic condition that may affect a study outcome variable.
- •Is using any systemic or topical medications that may affect ocular health.
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Mean End-of-Day Comfort
Time Frame: Hour 12
As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
Secondary Outcomes
- Mean Non-Invasive Tear Film Break-Up Time (NITBUT)(Hour 12)